{"id":50005,"date":"2024-08-26T08:48:32","date_gmt":"2024-08-26T06:48:32","guid":{"rendered":"https:\/\/clariscience.com\/blog\/uncategorized\/la-gestione-dei-rischi-dei-processi-aziendali-istruzioni-per-luso"},"modified":"2024-11-11T10:07:20","modified_gmt":"2024-11-11T09:07:20","slug":"risk-management","status":"publish","type":"post","link":"https:\/\/clariscience.com\/en\/blog\/quality\/risk-management","title":{"rendered":"Risk Management of business processes: instructions for use"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"50005\" class=\"elementor elementor-50005 elementor-46803\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9dcfcc0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9dcfcc0\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f2f064c\" data-id=\"f2f064c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2debf7e elementor-widget elementor-widget-text-editor\" data-id=\"2debf7e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Risk management of business processes is a requirement imposed by the ISO 13485 standard on organizations operating in the medical sector that choose to adopt it as a tool for establishing their Quality Management System. This requirement is briefly outlined in point 4.1.2: \u201cThe organization must [\u2026] apply a risk-based approach to the control of the appropriate processes necessary for the Quality Management System.\u201d<\/p><p>However, behind this simple statement lies a<strong> complex yet fundamental<\/strong> process for formulating business strategy and monitoring all activities carried out by the organization.<\/p><p>The process of managing risks in business processes can be conducted following the guidelines set out in <strong>ISO 31000<\/strong> (Risk Management \u2013 Guidelines) and can generally be outlined as follows:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-354f2c6 elementor-widget elementor-widget-image\" data-id=\"354f2c6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1280\" height=\"720\" src=\"https:\/\/clariscience.com\/wp-content\/uploads\/2024\/08\/Comunicazione-e-consultazione-1-1280x720.png\" class=\"attachment-large size-large wp-image-50020\" alt=\"\" srcset=\"https:\/\/clariscience.com\/wp-content\/uploads\/2024\/08\/Comunicazione-e-consultazione-1-1280x720.png 1280w, https:\/\/clariscience.com\/wp-content\/uploads\/2024\/08\/Comunicazione-e-consultazione-1-350x197.png 350w, https:\/\/clariscience.com\/wp-content\/uploads\/2024\/08\/Comunicazione-e-consultazione-1-768x432.png 768w, https:\/\/clariscience.com\/wp-content\/uploads\/2024\/08\/Comunicazione-e-consultazione-1-1536x864.png 1536w, https:\/\/clariscience.com\/wp-content\/uploads\/2024\/08\/Comunicazione-e-consultazione-1.png 1920w\" sizes=\"(max-width: 1280px) 100vw, 1280px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a1c36f elementor-widget elementor-widget-text-editor\" data-id=\"8a1c36f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The risk management activity should be entrusted to a <strong>qualified team formed for this purpose<\/strong>, usually consisting of at least <strong>management<\/strong> and process owners.<\/p><h2>Definition of Context<\/h2><p>Constant <strong>communication<\/strong> and <strong>consultation<\/strong> with internal and external stakeholders is crucial to ensure that the organization has a <strong>comprehensive understanding of the risks it must face.<\/strong><\/p><p>\u00a0<\/p><p>Before undertaking risk management activities for processes, it is essential to <strong>assess and understand the internal and external context<\/strong> of the organization, as both can significantly influence the parameters to be considered in risk management.<\/p><p>\u00a0<\/p><p>The <strong>internal context<\/strong> refers to any \u201cendogenous\u201d situation that may affect how the organization manages risk. The risk management process should <strong>align with the organization\u2019s culture, structure, and strategy.<\/strong><\/p><p>\u00a0<\/p><p>Parameters that can be considered in analyzing the <strong>external context<\/strong> include <strong>social and cultural aspects, legal and regulatory factors, technological<\/strong> considerations, as well as<strong> key trends<\/strong> that may impact the organization\u2019s objectives.<\/p><h2>Risk Management Process<\/h2><h4>Risk Identification<\/h4><p>The purpose of this first step is to <strong>identify events and situations<\/strong>\u2014along with their causes\u2014that could influence the achievement of business <strong>objectives<\/strong>. It is important to <strong>identify all critical processes<\/strong> (and any subprocesses) and, for each of them, to pinpoint individual risks with<strong> higher criticality<\/strong> based on the<strong> potential damage<\/strong> they can cause (e.g., organizational discomfort, economic hardship, reputational damage, harm to human\/environmental safety, etc.).<\/p><h4>Risk Analysis<\/h4><p>Risk analysis involves determining the<strong> consequences of each identified hazardous event<\/strong>, based on the <strong>severity of damage<\/strong>, the<strong> probability of occurrence<\/strong>, and considering any<strong> control measures<\/strong> already implemented.<\/p><p>Each hazardous event should be associated with a <strong>Severity Index (SI)<\/strong> and a <strong>Probability Index (PI)<\/strong>, as well as an <strong>Effectiveness Index (EI)<\/strong> of the existing control measures.<\/p><p>By combining these three indices, the risk associated with each hazardous event can be determined, specifically:<\/p><p><strong>Risk Index (RI) = SI \u00d7 PI \u00d7 EI<\/strong><\/p><h4>Risk Evaluation<\/h4><p>In this phase, the risk indices obtained from the analysis described above are <strong>compared with the acceptability criteria<\/strong> established by the organization. Evaluated risks can be classified as:<\/p><ul><li>Acceptable, therefore manageable<\/li><li>To be managed<\/li><li>Unacceptable, therefore intolerable<\/li><\/ul><p><strong>Acceptable<\/strong> risks should be those that are already <strong>adequately controlled<\/strong>, while <strong>unacceptable or manageable<\/strong> risks require specific <strong>treatment<\/strong> to be mitigated.<\/p><h2>Risk Treatment<\/h2><p>Risks evaluated as <strong>unacceptable<\/strong> or to be <strong>managed<\/strong> should be addressed by implementing <strong>additional appropriate mitigation actions.<\/strong> The <strong>risk treatment plan<\/strong> should describe at least the <strong>actions<\/strong> to be taken, the <strong>responsible<\/strong> parties for implementation and effectiveness verification, as well as the expected <strong>timelines<\/strong>. Each action should correspond to an <strong>Additional Effectiveness Index (AEI).<\/strong><\/p><p>The <strong>Residual Risk Index (RRI)<\/strong> can then be calculated:<\/p><p><strong>RRI = RI \u00d7 AEI<\/strong><\/p><p>The RRI should fall within the <strong>acceptable threshold or at least within the manageability threshold<\/strong>; otherwise, the organization should implement <strong>further risk mitigation actions.<\/strong><\/p><h2>Monitoring and Review<\/h2><p>The management of risks in business processes must be <strong>appropriately documented<\/strong> within a Quality Management System document. This document should be<strong> reviewed periodically<\/strong> and whenever <strong>changes are made to the organization\u2019s processes.<\/strong><\/p><p>In the case of a change, its impact on the company\u2019s Quality Management System and on the products and\/or services offered by the organization should be <strong>evaluated<\/strong>. For each change, any introduction of new risks or changes in the probability of occurrence of previously <strong>identified<\/strong> and<strong> evaluated risks<\/strong> should be analyzed.<\/p><p>If necessary, the organization should take <strong>appropriate actions<\/strong> to control new or modified risks.<\/p><h2>Benefits for the Organization<\/h2><p>In addition to meeting a requirement, the correct application of an adequate procedure for managing risks in business processes provides <strong>various business benefits<\/strong>, such as:<\/p><ul><li>Increased likelihood of successfully achieving set objectives<\/li><li>Improvement of corporate governance<\/li><li>Establishment of a reliable basis for decision-making and activity planning<\/li><li>Effective use of resources for addressing critical issues<\/li><li>Protection of company values such as know-how and reputation<\/li><li>Implementation of effective control measures<\/li><li>Enhanced performance and efficiency of the business<\/li><li>Satisfaction of customer requirements<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The risk management activity should be entrusted to a qualified team formed for this purpose, usually consisting of at least management and process owners.<\/p>\n","protected":false},"author":328,"featured_media":46808,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","powered_cache_disable_cache":false,"powered_cache_disable_css_optimization":false,"powered_cache_disable_js_optimization":false,"footnotes":""},"categories":[533],"tags":[575],"class_list":["post-50005","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality","tag-magazine-en"],"acf":[],"yoast_head":"<title>Risk Management of business processes | Clariscience Magazine<\/title>\n<meta name=\"description\" content=\"Process risk management is a complex activity, yet essential for shaping corporate strategy.\" \/>\n<meta name=\"robots\" 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